37394 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

and community-based services

whenever possible; ensuring EPSDT

screening and appropriate treatment for

children in foster care; and assisting the

Department in maintaining linkages

with schools for out-of-home placement,

facilitate return to school for the child

and family, and assist students who are

new to the school district due to foster

or adoptive placements.

To accomplish these services, WV

proposes a two-phase demonstration.

Phase one would pair community social

services agencies with middle schools

in Cabell County as resources for

information, assessments, and referrals.

Phase two proposes the hiring of fulltime prevention coordinators for each

school, beginning with two schools and

phasing in additional schools as

resources permit. Coordinators would

be school-based during the school year,

would serve as initial case managers

and advocates for the child/family,

provide direct services, and provide

follow-up with families over the

summer months.

The State’s hypothesis is that middle

school-based prevention and early

intervention programs would result in a

reduction of the number of children in

foster care, the average expense and

intensity of foster care, and the average

number of days children are in foster

care. This project would be limited to

Cabell County, in southwestern WV,

which includes six middle schools. The

project is proposed to begin in

September 1998 and would run through

August 2003.

The State requests waivers of title IV–

E to permit reimbursement for amounts

expended for children and families and

for purposes that are not normally

eligible under IV–E.

For evaluation purposes, the state

proposes to identify a control-group

county. Outcome measures would

include the number of children entering

foster care, the number of placements in

community-based or family settings,

and the number of days the children are

in foster care. Process evaluation

components include frequency and

types of intervention activities. An

outside evaluator would conduct the

evaluation.

Contact Person: Joan E. Ohl,

Secretary, Department of Health and

Human Resources, Bureau of Children &

Families/Office of Social Services,

Charleston, West Virginia 25305, Phone:

(304) 558–0684, Fax: (304) 558–1130.

Dated: June 25, 1998.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 98–18437 Filed 7–9–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0482]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection provisions

relating to the regulation of FDA’s

adverse experience reporting (AER) for

licensed biological products and general

records.

DATES: Submit written comments on the

collections of information by September

8, 1998.

ADDRESSES: Submit written comments

on the collections of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Jonnalynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c )(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collections of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Adverse Experience Reporting for

Licensed Biological Products—21 CFR

600.80, 600.81, and 600.90; and General

Records—21 CFR 600.12 (OMB Control

Number 0910–0308)—Extension

Under the Public Health Service Act

(42 U.S.C. 262), FDA is required to

ensure the marketing of only those

biological products that are safe and

effective. FDA must therefore be

informed of all adverse experiences

occasioned by the use of licensed

biological products. FDA issued the

adverse experience reporting

requirements to enable FDA to take

actions necessary for the protection of

the public health in response to reports

of adverse experiences related to

licensed biological products. The

primary purpose of FDA’s adverse

experience reporting system is to flag

potentially serious safety problems with

licensed biological products, focusing

especially on newly licensed products.

Although premarket testing discloses a

general safety profile of a new drug’s

comparatively common adverse effects,

the larger and more diverse patient

populations exposed to the licensed

biological product provides the

opportunity to collect information on

rare, latent, and long-term effects.

Reports are obtained from a variety of

sources, including patients, physicians,

foreign regulatory agencies, and clinical

investigators. Information derived from
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37395

the adverse experience reporting system

contributes directly to increased public

health protection because such

information enables FDA to recommend

important changes to the product’s

labeling (such as adding a new

warning), to initiate removal of a

biological product from the market

when necessary, and to assure the

manufacturer has taken adequate

corrective action if necessary.

Manufacturers of biological products

for human use must also keep records

of each step in the manufacture and

distribution of products including any

recalls of the product. The

recordkeeping requirements serve

preventative and remedial purposes.

These requirements establish

accountability and traceability in the

manufacture and distribution of

products, and enable FDA to perform

meaningful inspections.

Section 600.12 (21 CFR 600.12)

requires that all records of each step in

the manufacture and distribution of a

product be made and retained for no

less than 5 years after the records of

manufacture have been completed or 6

months after the latest expiration date

for the individual product, whichever

represents a later date. In addition,

records of sterilization of equipment

and supplies, animal necropsy records,

and records in cases of divided

manufacturing of a product are required

to be maintained. Section 600.12(b)(2)

requires complete records to be

maintained pertaining to the recall from

distribution of any product.

Section 600.80(c)(1) (21 CFR

600.80(c)(1)) requires the licensed

manufacturer to report each adverse

experience that is both serious and

unexpected, regardless of source, as

soon as possible but in any case within

15 working days of initial receipt of the

information. Section 600.80(e) requires

licensed manufacturers to submit a 15-

day alert report obtained from a

postmarketing clinical study only if

there is a reasonable possibility that the

product caused the adverse experience.

Section 600.80(c)(2) requires the

licensed manufacturer to report each

adverse experience not reported under

paragraph (c)(1) at quarterly intervals,

for 3 years from the date of issuance of

the product license, and then at annual

intervals. The majority of the periodic

reports will be submitted annually since

a large percentage of the current

licensed biological products have been

licensed longer than 3 years. Section

600.80(i) requires the licensed

manufacturers to maintain for a period

of 10 years records of all adverse

experiences known to the licensed

manufacturer, including raw data and

any correspondence relating to the

adverse experiences. Section 600.81 (21

CFR 600.81) requires the licensed

manufacturer to submit information

about the quantity of the product

distributed under the product license,

including the quantity distributed to

distributors at an interval of every 6

months. The semiannual distribution

report informs FDA of the quantity, the

lot number, and the dosage of different

products. Section 600.90 (21 CFR

600.90) requires a licensed

manufacturer to submit a waiver request

with supporting documentation when

asking for waiving the requirement that

applies to them under §§ 600.80 and

600.81.

Respondents to this collection of

information are manufacturers of

biological products. In fiscal year (FY)

1996, there were approximately 72

licensed manufacturers, 3 of which

submitted waiver requests under

§ 600.90 and were exempt from these

AER requirements. This number

excludes those manufacturers who

produce blood and blood components

and in vitro diagnostic licensed

products because they are specifically

exempt from the regulations. In FY

1996, there were 1,616 15-day alert

reports, 5,903 periodic reports and 464

distribution reports submitted to FDA.

The number of 15-day alert report for

postmarketing studies as stated in

§ 600.80(e) was minimal and is included

in the total number of 15-day alert

reports. The burden hours required to

complete the MedWatch Form for

§ 600.80(c)(1), (e), and (f) are reported

under OMB Control No. 0910–0291.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section No. of

Respondents

Number of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

600.80(c)(1) and 600.80(e) 69 23.4 1,616 1 1,616

600.80(c)(2) 69 85.6 5,903 1 5,903

600.81 69 6.7 464 1 464

600.90 3 1 3 1 3

1There are no capital costs or operating and maintenance costs associated with this collection of information.

There are approximately 391 licensed

manufacturers of biological products.

However, the number of recordkeepers

listed for § 600.12(a) through (e)

excluding (b)(2) is estimated to be 102.

This number excludes manufacturers of

blood and blood components because

their burden hours for recordkeeping

have been reported under 21 CFR

606.160 in OMB Control No. 0910–0116.

The recordkeeping burden is based on

the number of lots released (9,027), the

number of recalls made (710) and the

total number of AER reports received

(7,519) for FY 1996. FDA estimates that

the average time associated with

recordkeeping per lot is 32 hours, for

recalls is 24 hours, and for adverse

experience reports is 1 hour. FDA

estimates the burden of this

recordkeeping as follows:

TABLE 2.—Estimated Annual Recordkeeping Burden1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

600.12 102 88.5 9,027 2,832 288,864

600.12(b)(2) 391 1.8 710 43 16,813

600.80(i) 69 109 7,519 109 7,519

1There are no capital costs or operating and maintenance costs associated with this collection of information.
37396 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

Dated: June 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18402 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0510]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by August 10,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Current Good Manufacturing Practice

Regulations for Medicated Feeds (21

CFR Part 225) (OMB Control Number

0910–0152—Reinstatement)

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (cGMP)

regulations for drugs, including

medicated feeds. Medicated feeds are

administered to animals for the

prevention, cure, mitigation or

treatment of disease, or growth

promotion and feed efficiency. Statutory

requirements for cGMP’s have been

codified under part 225 (21 CFR part

225). Medicated feeds that are not

manufactured in accordance with these

regulations are considered adulterated

under section 501(a)(2)(B) of the act.

Under part 225, a manufacturer is

required to establish, maintain, and

retain records for a medicated feed,

including records to document

procedures required during the

manufacturing process to ensure proper

quality control is maintained. Such

records would, for example, contain

information concerning receipt and

inventory of drug components, batch

production, laboratory assay results (i.e.,

batch and stability testing), labels, and

product distribution.

This information is needed so that

FDA can monitor drug usage and

possible misformulation of medicated

feeds, to investigate violative drug

residues in products from treated

animals and to investigate product

defects when a drug is recalled. In

addition, FDA will use the cGMP

criteria in part 225 to determine

whether or not the systems and

procedures used by manufacturers of

medicated feeds are adequate to ensure

that their feeds meet the requirements of

the act as to safety and also meet their

claimed identity, strength, quality, and

purity, as required by section

501(a)(2)(B) of the act. A license is

required when the manufacturer of a

medicated feed involves the use of a

drug or drugs which FDA has

determined requires more control

because of the need for a withdrawal

period before slaughter or carcinogenic

concerns. Conversely, for those

medicated feeds for which FDA has

determined that the drugs used in their

manufacture need less control, a license

is not required and the recordkeeping

requirements are less demanding. The

respondents to this collection of

information are commercial feed mills

and mixer-feeders.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 1,600 24 38,400 0.41 16,000

225.58(c) and (d) 1,600 24 38,400 0.25 9,600

225.80(b)(2) 1,600 24 38,400 0.16 6,400

225.102(b)(1) through (b)(5) 1,600 24 38,400 1.0 38,400

225.110(b)(1) and (b)(2) 1,600 24 38,400 0.25 9,600

225.115(b)(1) and (b)(2) 1,600 24 38,400 0.25 9,600

Total burden hours 89,600

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2 Commercial feed mills.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 200 3 600 0.16 100

225.58(c) and (d) 200 3 600 0.16 100

225.80(b)(2) 200 3 600 0.083 50

225.102(b)(1) through (b)(5) 200 3 600 0.5 300

225.110(b)(1) and (b)(2) 200 3

225.115(b)(1) and (b)(2) 200 3